Vascular Endothelial Growth Factor A

血管内皮生长因子 A
  • 文章类型: Journal Article
    尽管在地理萎缩(GA)的详细成像方面具有广泛的可用性和共识,光谱域光学相干断层扫描(SD-OCT)可能受益于GA诊断中的自动定量OCT分析,监测,并报告其具有里程碑意义的临床试验。
    分析pegcetacoplan与一致GASD-OCT终点之间的关联。
    这是对来自2项平行3期研究的1258名参与者中的936名的11614个SD-OCT卷的事后分析,比较玻璃体腔内APL-2治疗与假注射治疗继发于年龄相关性黄斑变性(OAKS)的地理萎缩(GA)患者的疗效和安全性的研究,以及比较玻璃体腔内APL-2治疗的疗效和安全性的研究。OAKS和DERBY是24个月,多中心,随机化,双面蒙面,2018年8月至2020年7月,在眼底自发荧光成像上对总面积为2.5至17.5mm2的GA成人进行了假对照研究(如果多焦点,至少1个病灶≥1.25mm2)。这项分析是在2023年9月至12月进行的。
    研究参与者接受了pegcetacoplan,每0.1毫升玻璃体内注射15毫克,每月或每隔一个月,或假注射每月或每隔一个月。
    主要终点是3个治疗组中每个治疗组中的视网膜色素上皮面积和外部视网膜萎缩相对于基线的最小二乘均值变化(pegcetacoplan每月,pegcetacoplan每隔一个月,并在24个月时合并假[每月假和每隔一个月假])。通过早期治疗糖尿病视网膜病变研究(ETDRS)感兴趣区域(即,中央凹,侧腹,和中心凹)。
    在936名参与者中,平均(SD)年龄为78.5(7.22)岁,570名参与者(60.9%)为女性。Pegcetacoplan,但不是假治疗,在长达24个月的时间内,与GA的SD-OCT生物标志物的生长速率降低相关。在3至24个月的每个时间点均可检测到视网膜色素上皮和外部视网膜萎缩面积相对于基线的最小二乘均值(SE)变化(最小二乘均值与合并的假手术在24个月,pegcetacoplan每月:-0.86mm2;95%CI,-1.15至-0.57;P<.001;pegcetacoplan每隔一个月:-0.69;95%CI-39,P<这种关联在更频繁的给药(pegcetacoplan每月与pegcetacoplan每隔一个月在第24个月:-0.17mm2;95%CI,-0.43至0.08;P=.17)。在每月的pegcetacoplan和每隔一个月的pegcetacoplan中,在半凹和中央凹区域都观察到了更强的关联。
    这些发现为pegcetacoplan对GA发展的潜在影响提供了更多的见解,包括对视网膜色素上皮和光感受器的潜在影响。
    ClinicalTrials.gov标识符:NCT03525600和NCT03525613。
    UNASSIGNED: Despite widespread availability and consensus on its advantages for detailed imaging of geographic atrophy (GA), spectral-domain optical coherence tomography (SD-OCT) might benefit from automated quantitative OCT analyses in GA diagnosis, monitoring, and reporting of its landmark clinical trials.
    UNASSIGNED: To analyze the association between pegcetacoplan and consensus GA SD-OCT end points.
    UNASSIGNED: This was a post hoc analysis of 11 614 SD-OCT volumes from 936 of the 1258 participants in 2 parallel phase 3 studies, the Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OAKS) and Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (DERBY). OAKS and DERBY were 24-month, multicenter, randomized, double-masked, sham-controlled studies conducted from August 2018 to July 2020 among adults with GA with total area 2.5 to 17.5 mm2 on fundus autofluorescence imaging (if multifocal, at least 1 lesion ≥1.25 mm2). This analysis was conducted from September to December 2023.
    UNASSIGNED: Study participants received pegcetacoplan, 15 mg per 0.1-mL intravitreal injection, monthly or every other month, or sham injection monthly or every other month.
    UNASSIGNED: The primary end point was the least squares mean change from baseline in area of retinal pigment epithelium and outer retinal atrophy in each of the 3 treatment arms (pegcetacoplan monthly, pegcetacoplan every other month, and pooled sham [sham monthly and sham every other month]) at 24 months. Feature-specific area analysis was conducted by Early Treatment Diabetic Retinopathy Study (ETDRS) regions of interest (ie, foveal, parafoveal, and perifoveal).
    UNASSIGNED: Among 936 participants, the mean (SD) age was 78.5 (7.22) years, and 570 participants (60.9%) were female. Pegcetacoplan, but not sham treatment, was associated with reduced growth rates of SD-OCT biomarkers for GA for up to 24 months. Reductions vs sham in least squares mean (SE) change from baseline of retinal pigment epithelium and outer retinal atrophy area were detectable at every time point from 3 through 24 months (least squares mean difference vs pooled sham at month 24, pegcetacoplan monthly: -0.86 mm2; 95% CI, -1.15 to -0.57; P < .001; pegcetacoplan every other month: -0.69 mm2; 95% CI, -0.98 to -0.39; P < .001). This association was more pronounced with more frequent dosing (pegcetacoplan monthly vs pegcetacoplan every other month at month 24: -0.17 mm2; 95% CI, -0.43 to 0.08; P = .17). Stronger associations were observed in the parafoveal and perifoveal regions for both pegcetacoplan monthly and pegcetacoplan every other month.
    UNASSIGNED: These findings offer additional insight into the potential effects of pegcetacoplan on the development of GA, including potential effects on the retinal pigment epithelium and photoreceptors.
    UNASSIGNED: ClinicalTrials.gov Identifiers: NCT03525600 and NCT03525613.
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  • 文章类型: Journal Article
    目的:评估视网膜静脉阻塞(RVO)诊断和治疗临床实践指南(CPG)的方法学质量。
    方法:通过在数据库中搜索,对用于诊断和治疗RVO的CPGs进行了系统评价。元搜索引擎,CPG发展机构,眼科协会和CPG存储库,直到2022年4月。搜索更新于2023年4月进行,没有新记录可用。选择了过去10年以英语/西班牙语发布的五个CPG,5位作者独立评估了它们,使用评估研究和评估指南(AGREE-II)工具。按领域对每个CPG的单独评估(AGREE-II),对指南的总体评估,并在有或没有修改的情况下使用。此外,对最相关结局的建议进行了荟萃分析.
    结果:最低得分(平均18.8%)是领域5“适用性”,最高得分(平均62%)是第4域的“呈现清晰度”。2019年美国指南(PPP)在领域3“发展的严谨性”中得分最高(40.4%)。在评估所分析的CPG的整体质量时,所有CPG都可以推荐修改。在meta合成中,抗VEGF治疗是与RVO相关的黄斑水肿的首选治疗方法,但对于抗VEGF治疗的选择没有明确的建议.在评估的CPG中,诊断和随访建议相似。
    结论:根据AGREE-II评估,大多数用于诊断和治疗RVO的CPG的方法学质量较低。PPP在“发展的严谨性”领域中得分较高。在评估的CPG中,对于可选择的抗VEGF治疗类型没有明确的建议.
    OBJECTIVE: To assess the methodological quality of Clinical Practice Guidelines (CPG) for the diagnosis and management of Retinal Vein Occlusion (RVO).
    METHODS: A systematic review of CPGs for the diagnosis and management of RVO was carried out with a search in databases, metasearch engines, CPG development institutions, ophthalmology associations and CPG repositories until April 2022. Search update was performed on April 2023, with no new record available. Five CPGs published in the last 10 years in English/Spanish were selected, and 5 authors evaluated them independently, using the Appraisal of Guidelines for Research and Evaluation (AGREE-II) instrument. An individual assessment of each CPG by domain (AGREE-II), an overall assessment of the guide, and its use with or without modifications were performed. Additionally, a meta-synthesis of the recommendations for the most relevant outcomes was carried out.
    RESULTS: The lowest score (mean 18.8%) was for domain 5 \'applicability\', and the highest score (mean 62%) was for domain 4 \'clarity of presentation\'. The 2019 American guideline (PPP) presented the best score (40.4%) in domain 3 \'rigour of development\'. When evaluating the overall quality of the CPGs analysed, all CPGs could be recommended with modifications. In the meta-synthesis, anti-VEGF therapy is the first-choice therapy for macular oedema associated with RVO, but there is no clear recommendation about the type of anti-VEGF therapy to choose. Recommendations for diagnosis and follow-up are similar among the CPGs appraised.
    CONCLUSIONS: Most CPGs for the diagnosis and management of RVO have a low methodological quality assessed according to the AGREE-II. PPP has the higher score in the domain \'rigour of development\'. Among the CPGs appraised, there is no clear recommendation on the type of anti-VEGF therapy to choose.
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  • 文章类型: Journal Article
    药物的玻璃体内注射(IVI)允许活性成分的即时眼内浓度高于通过静脉内注射获得的浓度,同时降低全身副作用的风险。今天,IVI在许多玻璃体视网膜疾病的治疗中起着核心作用。随着人口老龄化和血管内皮生长因子(VEGF)拮抗剂的出现,他们的适应症呈指数增长,创建结构,组织和经济困难。IVI现在是工业化国家中最广泛使用的医疗程序之一,随着新分子的发展,其适应症有望在不久的将来进一步扩大。尽管这种做法的整体安全性得到了证明,IVI使患者面临0.05%的眼内炎风险,其后果往往是戏剧性的。本文详细介绍了当前的建议,特别是关于无菌和防腐,并提出了执行IVI的典型序列。
    Intravitreal injection (IVI) of a drug allows for immediate intraocular concentrations of active ingredients higher than those obtained by intravenous injection while reducing the risk of systemic side effects. Today, IVI\'s play a central role in the treatment of many vitreoretinal diseases. With the aging of the population and the advent of vascular endothelial growth factor (VEGF) antagonists, their indications have increased exponentially, creating structural, organizational and economic difficulties. IVI is now one of the most widely performed medical procedures in industrialized countries, and its indications are expected to expand further in the near future with the development of new molecules. Although the overall safety of this practice is proven, an IVI exposes the patient to a 0.05 % risk of endophthalmitis, the consequences of which are often dramatic. This article details the current recommendations, in particular regarding asepsis and antisepsis, and proposes a typical sequence for performing an IVI.
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  • 文章类型: Journal Article
    背景:视网膜疾病,包括湿性或干性年龄相关性黄斑变性,糖尿病性黄斑水肿,和糖尿病视网膜病变(DR),在美国被诊断和治疗不足。临床试验支持抗血管内皮生长因子(抗VEGF)治疗几种视网膜疾病的有效性,但是现实世界的数据表明临床医生的使用不足,导致患者经历较差的视觉结果随着时间的推移。继续教育(CE)在改变实践行为方面表现出了有效性,但需要更多的研究来了解CE是否可以帮助解决诊断和治疗差距。
    方法:该测试和对照配对分析检查了10,786名医疗保健从业人员中的视网膜疾病和基于指南的筛查和干预的测试前/测试后知识(即视网膜专家,眼科医生,验光师,初级保健提供者,糖尿病教育者,药剂师/管理护理专家,和其他医疗保健提供者,比如注册护士,执业护士,和医师助理)参与模块化,互动CE倡议。另一项医疗索赔分析提供了有关实践变化的数据,评估视网膜专家和眼科医生学习者(n=7,827)在教育前/后使用VEGF-A抑制剂,与匹配的非学习者对照组相比。结果是测试前/测试后知识/能力的变化和抗VEGF治疗应用的临床变化,正如医疗索赔分析所确定的那样。
    结果:学习者在早期识别和治疗方面的知识/能力得分显著提高,确定可以从抗VEGF药物中受益的患者,使用指南推荐的护理,认识到筛查和转诊的重要性,并认识到早期发现和护理DR的重要性(所有P值=0.003至0.004)。与匹配的对照相比,在CE干预后,学习者对视网膜疾病的抗VEGF药物的总注射量增加更多(P<0.001);特别是,与非学习者相比,处方的(新的)抗VEGF注射增加了18,513次(P<0.001)。
    结论:这种模块化,互动式,沉浸式CE计划在视网膜疾病护理提供者中带来了显著的知识/能力提升,并改变了与实践相关的治疗行为(即,与匹配的对照组相比,参与的眼科医生和视网膜专家适当考虑并更多地纳入指南推荐的抗VEGF治疗)。未来的研究将利用医疗索赔数据来显示该CE计划对专家治疗行为的纵向影响,以及对参与未来计划的验光师和初级保健提供者的诊断和转诊率的影响。
    BACKGROUND: Retinal diseases, including wet or dry age-related macular degeneration, diabetic macular edema, and diabetic retinopathy (DR), are underdiagnosed and undertreated in the United States. Clinical trials support the effectiveness of anti-vascular endothelial growth factor (anti-VEGF) therapies for several retinal conditions, but real-world data suggest underuse by clinicians, resulting in patients experiencing poorer visual outcomes over time. Continuing education (CE) has demonstrated effectiveness at changing practice behaviors, but more research is needed to understand whether CE can help address diagnostic and treatment gaps.
    METHODS: This test and control matched pair analysis examined pre-/post-test knowledge of retinal diseases and guideline-based screening and intervention among 10,786 healthcare practitioners (i.e., retina specialists, ophthalmologists, optometrists, primary care providers, diabetes educators, pharmacists/managed care specialists, and other healthcare providers, such as registered nurses, nurse practitioners, and physician assistants) who participated in a modular, interactive CE initiative. An additional medical claims analysis provided data on practice change, evaluating use of VEGF-A inhibitors among retina specialist and ophthalmologist learners (n = 7,827) pre-/post-education, compared to a matched control group of non-learners. Outcomes were pre-/post-test change in knowledge/competence and clinical change in application of anti-VEGF therapy, as identified by the medical claims analysis.
    RESULTS: Learners significantly improved knowledge/competence scores on early identification and treatment, identifying patients who could benefit from anti-VEGF agents, using guideline-recommended care, recognizing the importance of screening and referral, and recognizing the importance of early detection and care for DR (all P-values = 0.003 to 0.004). Compared with matched controls, learners\' incremental total injections for anti-VEGF agents for retinal conditions increased more after the CE intervention (P < 0.001); specifically, there were 18,513 more (new) anti-VEGF injections prescribed versus non-learners (P < 0.001).
    CONCLUSIONS: This modular, interactive, immersive CE initiative resulted in significant knowledge/competence gains among retinal disease care providers and changes in practice-related treatment behaviors (i.e., appropriate consideration and greater incorporation of guideline-recommended anti-VEGF therapies) among participating ophthalmologists and retina specialists compared to matched controls. Future studies will utilize medical claims data to show longitudinal impact of this CE initiative on treatment behavior among specialists and impact on diagnosis and referral rates among optometrists and primary care providers who participate in future programming.
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  • 文章类型: Journal Article
    背景在中国大陆,新生血管性年龄相关性黄斑变性(nAMD)患者的息肉状脉络膜血管病变(PCV)患病率约为40%.这种疾病会导致息肉,复发性视网膜色素上皮脱离(PED),广泛的视网膜下或玻璃体出血,和严重的视力丧失。中国在过去几年中引入了各种治疗方式,取得治疗PCV的全面经验是必要的。方法对全国14名具有PCV专业知识的视网膜专家进行培训,以确定六个问题的优先顺序并解决相应的结局。关于不活跃的PCV的意见,抗血管内皮生长因子(抗VEGF)单药治疗的选择,光动力疗法(PDT)单一疗法或联合疗法,负荷剂量抗VEGF后持续存在视网膜下液(SRF)或视网膜内液(IRF)的患者,或者视网膜下大量出血的患者.一个证据综合小组进行了系统评价,它通报了解决这些问题的建议。本指南使用了等级(建议的等级,评估,发展,和评估)评估证据的确定性并对建议的优势进行评级的方法。结果小组提出了以下关于治疗选择的六个有条件的建议:(1)对于不活跃的PCV患者,我们建议观察治疗;(2)对于治疗初期的PCV患者,我们建议抗VEGF单药或联合抗VEGF和PDT而不是PDT单药治疗;(3)对于计划开始抗VEGF和PDT联合治疗的PCV患者,我们建议后期/抢救PDT而不是开始PDT;(4)对于计划开始抗VEGF单药治疗的PCV患者,我们建议在三个月负荷剂量后治疗和延长(T&E)而不是先纳塔(PRN)方案;(5)对于在三个月负荷剂量后在光学相干断层扫描(OCT)上出现持续SRF或IRF的患者,我们建议继续抗VEGF治疗,而不是观察.(6)对于累及中央黄斑的大量视网膜下出血(等于或大于四个乳头直径)的PCV患者,我们建议手术(考虑使用补充疗法,例如,气动位移,抗VEGF,PDT,组织-纤溶酶原激活剂[t-PA])而不是抗VEGF单一疗法。结论:六项循证建议支持对PCV患者的最佳护理管理。
    Background In mainland China, patients with neovascular age-related macular degeneration (nAMD) have approximately an 40% prevalence of polypoidal choroidal vasculopathy (PCV). This disease leads to recurrent retinal pigment epithelium detachment (PED), extensive subretinal or vitreous hemorrhages, and severe vision loss. China has introduced various treatment modalities in the past years and gained comprehensive experience in treating PCV.Methods A total of 14 retinal specialists nationwide with expertise in PCV were empaneled to prioritize six questions and address their corresponding outcomes, regarding opinions on inactive PCV, choices of anti-vascular endothelial growth factor (anti-VEGF) monotherapy, photodynamic therapy (PDT) monotherapy or combined therapy, patients with persistent subretinal fluid (SRF) or intraretinal fluid (IRF) after loading dose anti-VEGF, and patients with massive subretinal hemorrhage. An evidence synthesis team conducted systematic reviews, which informed the recommendations that address these questions. This guideline used the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) approach to assess the certainty of evidence and grade the strengths of recommendations. Results The panel proposed the following six conditional recommendations regarding treatment choices. (1) For patients with inactive PCV, we suggest observation over treatment. (2) For treatment-na?ve PCV patients, we suggest either anti-VEGF monotherapy or combined anti-VEGF and PDT rather than PDT monotherapy. (3) For patients with PCV who plan to initiate combined anti-VEGF and PDT treatment, we suggest later/rescue PDT over initiate PDT. (4) For PCV patients who plan to initiate anti-VEGF monotherapy, we suggest the treat and extend (T&E) regimen rather than the pro re nata (PRN) regimen following three monthly loading doses. (5) For patients with persistent SRF or IRF on optical coherence tomography (OCT) after three monthly anti-VEGF treatments, we suggest proceeding with anti-VEGF treatment rather than observation. (6) For PCV patients with massive subretinal hemorrhage (equal to or more than four optic disc areas) involving the central macula, we suggest surgery (vitrectomy in combination with tissue-plasminogen activator (tPA) intraocular injection and gas tamponade) rather than anti-VEGF monotherapy. Conclusions Six evidence-based recommendations support optimal care for PCV patients\' management.
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  • 文章类型: English Abstract
    Age-related macular degeneration (AMD) is the main cause of low vision and even blindness in the elderly. With the aging of our population, the number of AMD patients will continue to rise. In the past decade, the rapid development of ocular fundus imaging technology has provided a new perspective and approach for the classification, diagnosis and follow-up of AMD. The advent of new drugs has provided more diverse intervention and treatment methods for AMD, especially for neovascular AMD, and the emphasis on accurate and individualized treatment has put forward higher requirements for retinal specialists. Therefore, based on the latest evidence-based medical information, combined with the international guidelines and the current situation of China\'s social and economic development, experts from the Chinese Vitreo-Retinal Society of Chinese Medical Association, the Fundus Disease Group of Chinese Ophthalmologist Association, and the National Clinical Research Center for Eye Diseases gave recommendations around eight clinical problems and formed China\'s guidelines for the clinical diagnosis and treatment of AMD. With the implementation of these guidelines, we can standardize the diagnosis, treatment, prevention and follow-up of AMD in China. (This article was published ahead of print on the official website of Chinese Journal of Ophthalmology on April 6, 2023).
    年龄相关性黄斑变性(AMD)是老年人群低视力乃至失明的主要原因,随着我国人口老龄化加剧,AMD的患病人数将持续上升。近10年,眼底影像学检查技术飞速发展,为AMD的分型、诊断和随访提供了新的视角和途径,新药的开发为AMD尤其新生血管性AMD提供了更为多样的干预和治疗方法,而强调精准个体化治疗对眼底病医师提出了更高要求。为此,中华医学会眼科学分会眼底病学组、中国医师协会眼科医师分会眼底病学组与国家眼部疾病临床医学研究中心基于最新循证医学证据,结合国际指南和我国社会经济发展现状,围绕8个临床问题提出推荐意见,形成了我国的AMD临床诊疗指南,以期加强和完善我国AMD诊疗工作的规范化,提高我国AMD的诊疗、预防和随访水平。(本文于2023年4月6日优先出版在中华眼科杂志官网).
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  • 文章类型: English Abstract
    Breast cancer is the most common cancer in the world, and 5-year survival rate of metastatic breast cancer is about 20%. The treatment of metastatic breast cancer is mainly chemotherapy, endocrine therapy and targeted therapy. However, after multiline treatment, patients with MBC especially the triple negative breast cancer face the problem of drug resistance. Tumor angiogenesis theory suggests that blocking angiogenesis can inhibit tumor growth and migration. Based on this, angiogenesis treatment strategy is proposed. Antiangiogenic drugs mainly include biological macromolecular drugs targeting vascular endothelial growth factor (VEGF) or vascular endothelial growth factor receptor (VEGFR) and small molecule VEGFR inhibitors. Angiogenesis is known to play a key role in the growth and metastasis of breast cancer. Therefore, anti-angiogenetic therapy has potential in metastatic breast cancer patients. Since the approval of tumor drug indications by NPMA in China is often later than the release of the latest research data, the National Health Commission issued \"the guiding principles for the clinical application of new antitumor drugs\" in 2020. The principle pointed out that under special circumstances such as the absence of better treatment, medical institutions should manage the usage of drugs that are not clearly defined in the instructions but have evidence-based data. Based on the latest research progress in breast cancer, the consensus writing expert group collated published reports, international academic conferences, conducted analysis, discussion and summary, collected data on the use of small molecule anti-vascular targeting drugs for advanced breast cancer, and formulated \"expert consensus on the application of small molecule anti-angiogenic drugs in the treatment of advanced breast cancer\" . For clinicians\' reference only.
    乳腺癌是全世界发病率最高的恶性肿瘤,晚期乳腺癌患者5年生存率仅为20%。晚期乳腺癌的治疗以化疗、内分泌治疗和靶向治疗为主,但经多线治疗后患者容易对药物产生耐药,特别是三阴性晚期乳腺癌。肿瘤血管生成学说认为阻断血管生成可以抑制肿瘤生长和迁移。抗血管生成类药物主要包括靶向血管内皮生长因子(VEGF)或血管内皮生长因子受体(VEGFR)的生物大分子药物以及小分子VEGFR抑制剂。血管生成在乳腺癌生长和转移扩散中发挥关键作用,因此,抗血管生成治疗在晚期乳腺癌中也具有临床潜力。中华人民共和国国家卫生健康委员会于2020年颁布的《新型抗肿瘤药物临床应用指导原则》指出,在尚无更好治疗手段等特殊情况下,医疗机构应当对说明书中未明确、但具有循证医学证据的药品用法进行管理。共识撰写专家组根据国内外乳腺癌研究进展,整理国内外已发表的文献及国际学术大会报道,进行分析、讨论和总结,对小分子抗血管靶向药用于晚期乳腺癌治疗的数据进行汇总,制定了小分子抗血管生成药物治疗晚期乳腺癌超说明书用药专家共识,仅供临床医师参考。.
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  • 文章类型: Journal Article
    目的:为转移性肾透明细胞癌(ccRCC)的治疗提供建议。
    方法:专家小组进行了系统的文献综述,以获取指导治疗建议的证据。
    结果:专家组审议了以英文发表的同行评审报告。
    结论:转移性ccRCC的诊断应使用原发肿瘤或转移部位的组织活检,并包括标记和/或染色以支持诊断。应使用国际转移性RCC数据库联盟风险标准来告知治疗。可以提供细胞减灭性肾切除术来选择患有原位肾脏和高危或中危疾病的患者。对于那些已经做了肾切除术的人来说,如果他们无症状且疾病负担低,则可以提供初始阶段的主动监测。需要全身治疗的高危疾病患者可接受免疫检查点抑制剂(ICI)与血管内皮生长因子受体(VEGFR)酪氨酸激酶抑制剂(TKI)的联合治疗;中危或低危患者应接受双重治疗方案(ICI或ICI与VEGFRTKI联合治疗未提供建议)。对于精选的患者,可以根据合并症提供ICI或VEGFRTKI的单药治疗.白细胞介素-2仍然是一种选择,尽管无法确定选择标准。还提供了二线和后续治疗以及骨转移治疗的建议,脑转移瘤,或存在肉瘤样特征。高度鼓励转移性ccRCC患者参与临床试验。其他信息可在www上获得。asco.org/泌尿生殖系统癌症指南。
    OBJECTIVE: To provide recommendations for the management of patients with metastatic clear cell renal cell carcinoma (ccRCC).
    METHODS: An Expert Panel conducted a systematic literature review to obtain evidence to guide treatment recommendations.
    RESULTS: The panel considered peer-reviewed reports published in English.
    CONCLUSIONS: The diagnosis of metastatic ccRCC should be made using tissue biopsy of the primary tumor or a metastatic site with the inclusion of markers and/or stains to support the diagnosis. The International Metastatic RCC Database Consortium risk criteria should be used to inform treatment. Cytoreductive nephrectomy may be offered to select patients with kidney-in-place and favorable- or intermediate-risk disease. For those who have already had a nephrectomy, an initial period of active surveillance may be offered if they are asymptomatic with a low burden of disease. Patients with favorable-risk disease who need systemic therapy may be offered an immune checkpoint inhibitor (ICI) in combination with a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI); patients with intermediate or poor risk should be offered a doublet regimen (no recommendation was provided between ICIs or an ICI in combination with a VEGFR TKI). For select patients, monotherapy with either an ICI or a VEGFR TKI may be offered on the basis of comorbidities. Interleukin-2 remains an option, although selection criteria could not be identified. Recommendations are also provided for second- and subsequent-line therapy as well as the treatment of bone metastases, brain metastases, or the presence of sarcomatoid features. Participation in clinical trials is highly encouraged for patients with metastatic ccRCC.Additional information is available at www.asco.org/genitourinary-cancer-guidelines.
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  • 文章类型: Journal Article
    肝细胞癌(HCC)是一种致命的癌症,在过去20年中发病率不断上升。当治愈性治疗不再可行时,大多数患者被诊断为晚期。以慢性肝病为背景,HCC的管理变得更加复杂,其中良好的肝功能是局部或全身治疗的先决条件。2008年,索拉非尼成为第一个被证明为晚期HCC患者提供生存益处的全身性药物。近十年来,没有任何治疗方法能够提供比索拉非尼更好的结果。然而,在过去的5年中,系统疗法取得了许多进展,以满足有效治疗选择的未满足需求。在III期临床试验中获得积极结果后,几种药物已被批准用于临床。包括lenvatinib,Regorafenib,卡博替尼,雷莫珠单抗,最后是免疫检查点抑制剂阿替珠单抗联合贝伐单抗,针对血管内皮生长因子的单克隆抗体。有各种选项可用,了解每种药物的临床证据,他们的安全概况,以及患者特征和偏好在临床决策中成为强制性的。这种共识的目的是帮助临床医生,卫生保健工作者,和政策制定者为HCC患者提供最佳临床护理。
    Hepatocellular carcinoma (HCC) is a deadly cancer with a rising incidence in the last 20 years. Most patients are diagnosed late when curative treatment is no longer feasible. With the background of chronic liver disease in most patients, the management of HCC becomes more complicated, in which well-preserved liver function is a prerequisite for locoregional or systemic therapies. In 2008, sorafenib became the first systemic agent proven to provide survival benefit for patients with advanced-stage HCC. For nearly a decade, no treatment has succeeded in providing better results than sorafenib. However, numerous advances in systemic therapies have emerged in the last 5 years to fulfill the unmet needs of effective therapeutic options. Several agents have been approved for clinical use after positive results in phase III clinical trials, including lenvatinib, regorafenib, cabozantinib, ramucirumab, and lastly immune checkpoint inhibitor atezolizumab in combination with bevacizumab, a monoclonal antibody targeting the vascular endothelial growth factor. With various options available, knowledge on the clinical evidence of each drug, their safety profile, as well as the patient characteristics and preferences become mandatory in clinical decision making. The objective of this consensus is to help clinicians, health-care workers, and policy makers in providing best clinical care for HCC patients.
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  • 文章类型: Journal Article
    Vascular damage is followed by vascular endothelial growth factor (VEGF) expression at high levels, which is an important mechanism for cerebral radiation necrosis (CRN) development. Antiangiogenic agents (Bevacizumab) alleviates brain edema symptoms caused by CRN through inhibiting VEGF and acting on vascular tissue around the brain necrosis area. Many studies have confirmed that Bevacizumab effectively relieves symptoms caused by brain necrosis, improves patients\' performance status and brain necrosis imaging. Considering that the efficacy of antiangiogenic therapy is mainly related to the duration of drug action, low-dose antiangiogenic agents can achieve favorable efficacy. Prevention is the best treatment. The occurrence of CRN is associated with tumor-related factors and treatment-related factors. By controlling these factors, CRN can be effectively prevented.
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    【中文题目:抗血管药物治疗放射性脑坏死专家共识】 【中文摘要:血管内皮生长因子(vascular endothelial growth factor, VEGF)的高水平表达是放射性脑坏死(cerebral radiation necrosis, CRN)发生的重要机制。抗血管生成药物(贝伐珠单抗)通过抑制VEGF,作用于脑坏死区域周围的血管组织,减轻CRN引起的脑水肿。许多研究证实贝伐珠单抗可有效缓解脑坏死症状,改善患者的体力状况评分以及减轻影像学上脑水肿范围。抗血管治疗的疗效主要与药物作用时长相关,低剂量抗血管药物即可达到较好的治疗效果。预防是最好的治疗,CRN的发生与肿瘤相关因素和治疗相关因素相关,通过控制两方面因素,可有效预防CRN。
】 【中文关键词:放射性脑坏死;抗血管生成药物;贝伐珠单抗;专家共识】.
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